SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. announced that additional results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI) were presented today by clinical investigator, Mark A. Miller, M.D., at the Digestive Disease Week 2009 conference in Chicago.
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The additional data presented today for the first time focused on other patient risk factors believed to be predictive of CDI recurrence following treatment. These risk factors include serum albumin levels, white blood cell (WBC) count and temperature, and non-BI (NAP1/027) strains. The data showed that fidaxomicin overall demonstrated a lower recurrence rate compared to oral vancomycin (Vancocin(R)) regardless of albumin levels, WBC count and temperature, as well as for patients with non-BI (NAP1/027) strains. Vancocin is currently the only FDA approved therapy for CDI.
Recurrence Rates by Subgroup (per protocol)
Dr. Miller also presented the previously announced top-line results and data related to patient status (in-patient/out-patient), age (under/over 65) and the strain type BI (NAP1/027).
“The subgroup analysis shows that fidaxomicin is more effective than oral vancomycin when it comes to reducing recurrence, even in high risk patient populations such as those older than 65, hospitalized patients, and patients with very low albumin levels,” said Mark A. Miller, M.D., Chief of Clinical Microbiology, Head of the Division of Infectious Diseases, Chair of the Infection Prevention and Control Unit at Jewish General Hospital and Associate Professor of Medicine and Microbiology/Immunology at McGill University in Montreal, Quebec, Canada.
Additional analyses from this study will be presented at medical conferences throughout the year.
Fidaxomicin Clinical Study Design
629 adult subjects were enrolled in this multi-center, randomized, double-blind Phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI.
The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator. The secondary endpoint evaluated CDI recurrence up to four weeks post therapy with recurrence defined as the return of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients who were cured and did not have a recurrence.
About Clostridium Difficile Infection
CDI has become a growing problem in hospitals, long-term care facilities and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. CDI typically develops from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, allowing C. difficile bacteria to flourish.
Current therapeutic options for CDI include metronidazole and oral vancomycin. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.
Primary risk factors for CDI include broad-spectrum antibiotic use, advanced age (over 65), emerging hyper-virulent strains (BI /NAP1/027, 078, 001) of C. difficile, and previous exposure to CDI that lead to recurrence. Higher incidence, increased treatment failures, and recurrence with standard therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials.
Scheduled Conference Call
The Company will host a conference call for the investment community today beginning at 3:00 p.m. Pacific time (6:00 p.m. Eastern time) to discuss the additional fidaxomicin Phase 3 data and answer questions.
To participate in the live call by telephone, please dial (877) 419-6590 from the U.S., or (719) 325-4893 from outside the U.S. The conference call will be webcast live under the Investors section of Optimer’s website at www.optimerpharma.com.
About Fidaxomicin
Fidaxomicin is the first in a new class of antibiotics called macrocyclics, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile. The narrow spectrum profile of fidaxomicin may eradicate Clostridium difficile selectively with minimal disruption to the normal intestinal flora. This may facilitate the return of the normal physiological conditions in the colon and reduce the probability of CDI recurrence.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection. Prulifloxacin is an antibiotic which has completed two Phase 3 clinical trials for the treatment of travelers’ diarrhea, a form of infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Forward-looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the ability of fidaxomicin to address current treatment limitations and the presentation of future clinical trial results. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer’s filings with the Securities and Exchange Commission.
CONTACT: John Prunty, CFO & VP - Finance, or Christina Donaghy, Corporate
Communications Manager, both of Optimer Pharmaceuticals, Inc.,
+1-858-909-0736; or Jason I. Spark, Vice President of Porter Novelli Life
Sciences, +1-619-849-6005, for Optimer Pharmaceuticals, Inc.
Web site: http://www.optimerpharma.com/
